MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF TORIC ASPHERIC UV ABSORBING SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	SA6AT4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned adhered to the inside of a company product tray.Viscoelastic was observed on the lens.Both haptics were broken in the distal area.The broken portion of the haptics were not returned.The lens was cleaned with klrp to further evaluate.The optic was cut into two portions.One optic portion has linear cracks in the shape of an instrument used to grasp the lens.The anterior optic has scratches between the center and the edge.The other optic portion has many cracked areas on the edge.The posterior optic edge is split and chipped.Product history records were reviewed, and documentation indicated the product met release criteria.Information was provided that indicated the use of a qualified cartridge, handpiece, and viscoelastic combination.The root cause cannot be determined for the reported complaint of dysphotopsia, explant.The explanted lens was returned in pieces with broken haptics and multiple areas of damage to the optic.Each lens was subjected to a 100 percentage assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The power and resolution of the returned lens could not be re-evaluated due to the optic damage.The monofocal toric company (2.25 cyl.) 14.5 diopter lens was removed and replaced with a non-company monofocal, 14.5 diopter.Due to the exchange of a monofocal toric 14.5 diopter lens to a monofocal non-toric 14.5 diopter lens, this suggests that a non-toric lens to an for the replacement lens may have been an improved choice for the patient's vision needs.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that following an intraocular lens (iol) implant procedure in left eye, the patient experienced dysphotopsia.The iol was exchanged for same diopter non-company lens 1 year 4 months 9 days following the initial implant procedure.Post exchange the patient issues were resolved and surgeon prognosis was stable vision with no patient harm.Additional information has been requested.

• Brand Name: ACRYSOF TORIC ASPHERIC UV ABSORBING SINGLEPIECE IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21514474
• Report Number: 1119421-2025-00585
• Device Sequence Number: 19958543
• Product Code: HQL
• UDI-Device Identifier: 00380652336185
• UDI-Public: (01)00380652336185(17)231031(11)181107(10)12666958
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: SA6AT4
• Device Lot Number: 12666958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH II LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female